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비즈니스 · 1994. 8. 25.1 분 읽기
Toray Industries (America), Inc.; Premarket Approval of the Inoue Balloon Catheter
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요약
The Food and Drug Administration (FDA) is announcing its approval of the application by Toray Industries (America), Inc., New York, NY, for premarket approval, under section 515 of the Federal Food, Drug, and Cosmetic Act (the act), of the Inoue Balloon Catheter. After reviewing the recommendation of the Circulatory System Devices Panel, FDA's Center for Devices and Radiological Health (CDRH) notified the applicant, by letter on June 28, 1994, of the approval of the application.
원본 출처 언어: Federal Register — Health and Human Services원문 발표 열기 →